Develop a Device Master Record that can assist with Device History Record Review


Instructor: Mary Nunnally
Product ID: 705328

  • Duration: 60 Min
This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
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Why Should You Attend:

This webinar will cover basic requirements for the content of a Device Master Record for compliance to 21CFR 820 and ISO 13485:2016 and will review potential differences in the requirements between the two regulatory standards. It will further discuss the difference between a Device Master Record (DMR) and a Device History Record (DHR) including the differences, if any, between a device Batch Record and a Device History Record?

Attendees will learn how a DMR can assist with compilation and quality assurance review of a DHR – especially for device products with multiple components. It will further help them understand what document control means for DMR documents (records).

Areas Covered in the Webinar:

  • Records required for the Device Master Record
  • How to use the Device Master Record to develop a method for efficient Device History (Record Batch Record) review and product release?
  • What are the responsibilities of various development team members – such as R&D/engineering, operations, quality assurance, project management and executive management?
  • When should a Device Master Record be established for a product in development?

Who Will Benefit:

  • Quality assurance personnel responsible for compliance audits of Device History Records and subsequent medical device product release
  • Operations personnel responsible for production of medical devices
  • R & D scientists within the medical device Industry
  • Project managers working with medical device development teams
Instructor Profile:
Mary Nunnally

Mary Nunnally
President, Translational Medicine LLC

Mary H Nunnally, PhD, is an experienced Quality and Operations Executive (20+ years) within the medical device, biomedical research product, veterinary medicine and pharmaceutical industries. She has an extensive hands-on experience in the establishment and maintenance of US FDA 21CFR 820, ISO 13485 and ISO 9001certified Quality Systems, including implementation of all systems required for compliance with US, CMDR, and EU regulatory statutes.

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